TOPIC: Critical Care
TYPE: Original Investigations
PURPOSE: Dexamethasone has become the standard of care for treating patients with coronavirus disease 2019 (COVID-19) who require oxygen. This therapeutic regiment has been found to decrease mortality in patients with COVID-19. The RECOVERY trial proposed utilizing dexamethasone at 6 mg daily, but some feel this dose is not high enough to ameliorate the cytokine storm in patients. Studies like DEXA-ARDS have utilized higher doses of dexamethasone (20 mg IV daily) found patients to have accelerated from the ventilator and more ventilator free days. Despite the increasing evidence of the effectiveness of corticosteroids for the treatment of moderate to severe COVID-19, the optimal dose of dexamethasone is not clearly stablished. We sought out to compare a low-dose dexamethasone against a high-dose of dexamethasone in patients admitted with COVID-19 to our tertiary hospital in Honduras.
METHODS: We conducted a single center a randomized non-blinded control trial pilot study of COVID-19 patients admitted between September 1st 2020 to October 31st2020.
Patients were randomly assigned to be treated with low-dose dexamethasone (control) 8mg/day (n=40) and high-dose dexamethasone (experimental) 24mg/day. The primary outcome was the reduction in mortality and intubation. Our Secondary outcomes included nosocomial infections, superinfections and prolonged hospitalization.
RESULTS: A total of 81 patients underwent randomization, with 40 in the low-dose group and 41 in the high-dose group. On the low-dose n=17 (42.5%) were male and n=23 (57.5%) were females vs the high-dose n=29(70.7%) were males and n=12(29.3%) were females. Patient’s were similarly matched in age, with (mean +/-SD) of 56.9 +/- 14.9 and 57.5+/-16.5 for low and high-dose dexamethasone respectively. Oxygen saturation on admission was 77.8% in the high-dose vs 82.5% in the low-dose group. C reactive protein (CRP) mean value was 52.8 mg/L in low-dose vs 79.65 in the high-dose. Patients in the high-dose group developed more nosocomial infections (19.5% (n=8)) compared to their low-dose counterparts (12.5% (n=5)). Patients in the high dose group were more likely to become more critically ill (53.7% (n=22)) than their low-dose peers (27.5% (n=11)). The risk of becoming critically ill and requiring intubation was near 2-fold higher in the high-dose as opposed to the low dose group RR=1.95 (95% CI 1.1-3.5). A total of 8 patients died, with 6 of these patients being in the high-dose group.
CONCLUSIONS: High dose of dexamethasone was associated with increased mortality, risk of intubation and nosocomial infections. It is likely that patients who were enrolled in the high-dose corticosteroid group were sicker, as evidenced by the higher CRP levels and low SpO2 on admission in this cohort. Our study is limited by a small sample size but the findings remain significant as this is the only randomized trial looking at differences between high and low doses of dexamethasone in a LMIC.
CLINICAL IMPLICATIONS: Low dose treatment showed increase in survival and better clinical outcomes. High-dose steroid use should be avoided. These findings can help guide clinical decision in LMIC were immunomodulation with monoclonal antibodies might not be feasible due to cost prohibition.
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